Applicator head with dosing aid

ABSTRACT

There is provided an applicator head (10) for administration of a topical formulation, comprising a dosing aid for application of a predefined dose of the topical formulation. The applicator head (10) comprises an applicator surface (20) adapted to apply the topical formulation to a user&#39;s skin. The applicator surface (20) comprises an outlet opening (40). The dosing aid comprises a dose marking, or dose markings (60, 60′, 60″, 62′, 62″) on the applicator surface (20), and wherein the dose marking (60, 60′, 60″, 62′, 62″) circumscribes an inner dosing compartment (64) that serves to measure the predefined dose of the topical formulation, and wherein the outlet opening (40) is disposed inside the inner dosing compartment.

FIELD OF THE INVENTION

This application is directed to improved applicator heads forapplication of topical formulations such as creams or gels.

BACKGROUND TO THE INVENTION

Specialized packaging for topical formulations such as creams, gels,ointments or the like can be equipped with applicator heads. Applicatorheads comprise an outlet opening for expulsion of product from thepackaging, and an applicator surface for applying the expelled productonto the skin. An example of such a packaging is disclosed inWO2014/170841. Applicator surfaces can additionally comprise surfaceundulations such as massage bumps. Surface undulations provide a massageeffect when an applicator head is used to rub product into the skin.

These types of packaging with applicator heads however do not compriseany means for dosing of a product. With packaging of the art, the onlyway to achieve adequate dosing of a topical formulation is by applying aline of product of a prescribed length onto the skin. Users, whenapplying a line of product, have to estimate a length of this line ofproduct. Instructions for use usually prescribe a length for apredefined dose. Estimation is however not a precise way of dosing.

Doses applied can vary significantly. Especially in the field of topicalmedicines, this is not acceptable in view of patient safety. Therefore,in other cases, users measure a length of a line of product with help ofa dosing card. A dosing card usually is a plastic card comprising aprinted line of a predefined length. The printed line is used as areference. For example, a dosing card can comprise a printed line of alength of 6 cm, which corresponds to a predefined dose. A user has toposition the dosing card on his or her skin, and then apply a line ofproduct, having the same length as the reference line on the dosingcard, onto the skin. Alternatively, a user has to dose a line of producthaving the same length as the reference line onto the dosing card, andthen apply the product from the dosing card to the desired skin area.Dosing with a dosing card may be more accurate than dosing based onestimation. However, dosing with a dosing card is more difficult,unhygienic, and inconvenient. This dosing and application procedure cantherefore be cumbersome for users and be especially difficult forpatients who use a topical formulation for the treatment of pain, suchas arthritis, as they have to handle both the container of the productand the dosing card simultaneously to dispense an accurate dose. It canfurthermore often be messy when the package, the dosing card, or thehands of the user are spilled with product. The dosing card then has tobe cleaned and dried for storage and further use. The dosing card canalso be lost by the user. Additionally, users sometimes do notunderstand how to use the dosing card.

Both, dosing with and without a dosing card, have another significantdrawback. With both dosing methods, users cannot benefit from using anapplicator surface to rub the product directly onto the desired area.

There is thus a need for a dosing method and dosing aid that can be usedin combination with applicator heads for packaging of topicalcompositions. This is especially crucial for the packaging of topicalmedicines. The dosing aid should allow precise dosing. It should alloweasy handling and intuitive dosing. The dosing procedure should be cleanand not messy. It should require a minimal number of parts.

SUMMARY

This disclosure provides an applicator head for administration of atopical formulation, comprising a dosing aid for application of apredefined dose of the topical formulation, wherein the applicator headcomprises an applicator surface adapted to apply the topical formulationto a user's skin, wherein the applicator surface comprises an outletopening, and wherein the dosing aid comprises a dose marking on theapplicator surface, wherein the dose marking circumscribes an innerdosing compartment that serves to measure the predefined dose of thetopical formulation, and wherein the outlet opening is disposed insidethe inner dosing compartment.

In one embodiment, the dose marking has an outline that is at leastpartially circular, the circular part of the outline having a diameterD. In one embodiment, the dose marking has a completely circularoutline. In one embodiment, the dose marking is partially circular andpartially ellipsoid. In one embodiment, the outlet opening is disposedcentrally of the circular part of the outline of the dose marking.

In one embodiment, diameter D is selected such that, when the topicalformulation is ejected from the outlet opening, the amount of topicalformulation that spreads from the outlet opening and over the innerdosing compartment until it reaches the dose marking, corresponds to thepredefined dose.

In one embodiment, the dose marking is a visual dose marking.

In one embodiment, the dose marking is realized on the applicatorsurface by surface treatment of the applicator surface, application ofcolor markings on the applicator surface, by producing the applicatorsurface from several materials, wherein a border between two distinctmaterials serves as the dose marking, or by moulding-in of the dosemarking into the applicator surface.

In one embodiment, the dose marking has a color that is different fromthe color of a rest of the applicator surface.

In one embodiment, the dose marking flushes with the applicator surface.

In one embodiment, the dosing aid is adapted for dosing of twopredefined doses of topical formulation.

In one embodiment, there is more than one dose marking on the applicatorsurface, and the dose markings are arranged on the applicator surfaceconcentric around the outlet opening.

In one embodiment, there are a first and a second dose marking on theapplicator surface, wherein the first dose marking is arranged betweenthe outlet opening and the second dose marking, and wherein the firstand second dose marking between them circumscribe a ring dosingcompartment, and wherein the ring dosing compartment has a ring width Wthat is the distance between the first and the second dose marking.

In one embodiment, the ring width W is selected such that when thetopical formulation is ejected from the outlet opening, the amount oftopical formulation that spreads from the outlet opening and over theinner dosing compartment and further over the ring dosing compartmentuntil it reaches the second dose marking, corresponds to a secondpredefined dose.

In one embodiment, the applicator surface is manufactured bybi-injection moulding.

In one embodiment, the diameter D of the first dose marking is about 19mm to about 21 mm.

In one embodiment, the diameter D of the second dose marking is about 25mm to about 27 mm and the ring width W is about 0.8 mm to about 3 mm.

There is also provided an applicator head for administration of atopical formulation, comprising a dosing aid for application of apredefined dose of the topical formulation, wherein the applicator headcomprises an applicator surface adapted to apply the topical formulationto a user's skin, wherein the applicator surface comprises multipleoutlet openings, and wherein the dosing aid comprises a dose marking onthe applicator surface, wherein the dose marking has an outline that isat least partially circular, the circular part of the outline having adiameter D, and wherein the outlet openings are disposed on theapplicator surface point symmetrically to a center of the circular partof the outline of the dose marking, and wherein the dose markingcircumscribes an inner dosing compartment that serves to measure thepredefined dose of the topical formulation.

There is also provided a packaging for a topical formulation comprisingan applicator head as disclosed herein.

There is furthermore provided a product comprising a packaging asdisclosed herein containing a topical formulation. There is furthermoreprovided a product as described herein, wherein the topical formulationhas a viscosity in the range of about 1 Pa·s to about 4 Pa·s.

There is also provided a method of dosing a topical formulation with apackaging as disclosed herein, comprising the steps of: Urging thetopical formulation from the packaging and out of the outlet opening onthe applicator surface, letting the topical formulation spread over theapplicator surface until it covers the inner dosing compartment, andstopping urging of the topical formulation as soon as the topicalformulation covers the inner dosing compartment. This disclosure alsoprovides an applicator head for administration of a topical formulation,comprising a dosing aid for application of a predefined dose of thetopical formulation, wherein the applicator head comprises an applicatorsurface adapted to apply the topical formulation to a user's skin,wherein the applicator surface comprises an outlet opening, and whereinthe dosing aid comprises a dose marking on the applicator surface,wherein the dose marking has an outline that is at least partiallycircular, the circular part of the outline having a diameter D, andwherein the dose marking circumscribes an inner dosing compartment thatserves to measure the predefined dose of the topical formulation, andwherein the outlet opening is disposed inside the inner dosingcompartment, wherein the diameter D is selected such that, when thetopical formulation is ejected from the outlet opening, the amount oftopical formulation that spreads from the outlet opening and over theinner dosing compartment until it reaches the dose marking, correspondsto the predefined dose, and wherein the dose marking is a visual dosemarking.

This disclosure also provides an applicator head for administration of atopical formulation, comprising a dosing aid for application of apredefined dose of the topical formulation, wherein the applicator headcomprises an applicator surface adapted to apply the topical formulationto a user's skin, wherein the applicator surface comprises an outletopening, and wherein the dosing aid comprises a dose marking on theapplicator surface, wherein the dose marking has an outline that is atleast partially circular, the circular part of the outline having adiameter D, and wherein the dose marking circumscribes an inner dosingcompartment that serves to measure the predefined dose of the topicalformulation, and wherein the outlet opening is disposed inside the innerdosing compartment, wherein the diameter D is selected such that, whenthe topical formulation is ejected from the outlet opening, the amountof topical formulation that spreads from the outlet opening and over theinner dosing compartment until it reaches the dose marking, correspondsto the predefined dose, wherein the dose marking is a visual dosemarking, and wherein the dose marking is realized on the applicatorsurface by surface treatment of the applicator surface, application ofcolor markings on the applicator surface, by producing the applicatorsurface from several materials, wherein a border between two distinctmaterials serves as the dose marking, or by moulding-in of the dosemarking into the applicator surface.

This disclosure also provides an applicator head for administration of atopical formulation, comprising a dosing aid for application of apredefined dose of the topical formulation, wherein the applicator headcomprises an applicator surface adapted to apply the topical formulationto a user's skin, wherein the applicator surface comprises an outletopening, and wherein the dosing aid comprises a dose marking on theapplicator surface, wherein the dose marking has an outline that is atleast partially circular, the circular part of the outline having adiameter D, and wherein the dose marking circumscribes an inner dosingcompartment that serves to measure the predefined dose of the topicalformulation, and wherein the outlet opening is disposed inside the innerdosing compartment, wherein the diameter D is selected such that, whenthe topical formulation is ejected from the outlet opening, the amountof topical formulation that spreads from the outlet opening and over theinner dosing compartment until it reaches the dose marking, correspondsto the predefined dose, and wherein the dose marking is realized on theapplicator surface by surface treatment of the applicator surface,application of color markings on the applicator surface, by producingthe applicator surface from several materials, wherein a border betweentwo distinct materials serves as the dose marking, or by moulding-in ofthe dose marking into the applicator surface.

This disclosure also provides an applicator head for administration of atopical formulation, comprising a dosing aid for application of apredefined dose of the topical formulation, wherein the applicator headcomprises an applicator surface adapted to apply the topical formulationto a user's skin, wherein the applicator surface comprises an outletopening, and wherein the dosing aid comprises a dose marking on theapplicator surface, wherein the dose marking has an outline that is atleast partially circular, the circular part of the outline having adiameter D, and wherein the dose marking circumscribes an inner dosingcompartment that serves to measure the predefined dose of the topicalformulation, and wherein the outlet opening is disposed inside the innerdosing compartment, wherein the dose marking is a visual dose marking,and wherein the dose marking is realized on the applicator surface bysurface treatment of the applicator surface, application of colormarkings on the applicator surface, by producing the applicator surfacefrom several materials, wherein a border between two distinct materialsserves as the dose marking, or by moulding-in of the dose marking intothe applicator surface.

This disclosure also provides an applicator head for administration of atopical formulation, comprising a dosing aid for application of apredefined dose of the topical formulation, wherein the applicator headcomprises an applicator surface adapted to apply the topical formulationto a user's skin, wherein the applicator surface comprises an outletopening, and wherein the dosing aid comprises a dose marking on theapplicator surface, wherein the dose marking has an outline that is atleast partially circular, the circular part of the outline having adiameter D, and wherein the dose marking circumscribes an inner dosingcompartment that serves to measure the predefined dose of the topicalformulation, and wherein the outlet opening is disposed inside the innerdosing compartment, wherein the dose marking is realized on theapplicator surface by surface treatment of the applicator surface,application of color markings on the applicator surface, by producingthe applicator surface from several materials, wherein a border betweentwo distinct materials serves as the dose marking, or by moulding-in ofthe dose marking into the applicator surface, wherein the dose markinghas a color that is different from the color of a rest of the applicatorsurface.

This disclosure also provides an applicator head for administration of atopical formulation, comprising a dosing aid for application of apredefined dose of the topical formulation, wherein the applicator headcomprises an applicator surface adapted to apply the topical formulationto a user's skin, wherein the applicator surface comprises an outletopening, and wherein the dosing aid comprises a dose marking on theapplicator surface, wherein the dose marking has an outline that is atleast partially circular, the circular part of the outline having adiameter D, and wherein the dose marking circumscribes an inner dosingcompartment that serves to measure the predefined dose of the topicalformulation, and wherein the outlet opening is disposed inside the innerdosing compartment, wherein the diameter D is selected such that, whenthe topical formulation is ejected from the outlet opening, the amountof topical formulation that spreads from the outlet opening and over theinner dosing compartment until it reaches the dose marking, correspondsto the predefined dose, wherein the dose marking is a visual dosemarking, wherein the dose marking is realized on the applicator surfaceby surface treatment of the applicator surface, application of colormarkings on the applicator surface, by producing the applicator surfacefrom several materials, wherein a border between two distinct materialsserves as the dose marking, or by moulding-in of the dose marking intothe applicator surface, and wherein the dose marking has a color that isdifferent from the color of a rest of the applicator surface.

This disclosure also provides an applicator head for administration of atopical formulation, comprising a dosing aid for application of apredefined dose of the topical formulation, wherein the applicator headcomprises an applicator surface adapted to apply the topical formulationto a user's skin, wherein the applicator surface comprises an outletopening, and wherein the dosing aid comprises a dose marking on theapplicator surface, wherein the dose marking has an outline that is atleast partially circular, the circular part of the outline having adiameter D, and wherein the dose marking circumscribes an inner dosingcompartment that serves to measure the predefined dose of the topicalformulation, and wherein the outlet opening is disposed inside the innerdosing compartment, wherein the diameter D is selected such that, whenthe topical formulation is ejected from the outlet opening, the amountof topical formulation that spreads from the outlet opening and over theinner dosing compartment until it reaches the dose marking, correspondsto the predefined dose, wherein the dose marking is a visual dosemarking, wherein the dose marking is realized on the applicator surfaceby surface treatment of the applicator surface, application of colormarkings on the applicator surface, by producing the applicator surfacefrom several materials, wherein a border between two distinct materialsserves as the dose marking, or by moulding-in of the dose marking intothe applicator surface, and wherein the dose marking has a color that isdifferent from the color of a rest of the applicator surface, andwherein the dose marking flushes with the applicator surface.

This disclosure also provides an applicator head for administration of atopical formulation, comprising a dosing aid for application of apredefined dose of the topical formulation, wherein the applicator headcomprises an applicator surface adapted to apply the topical formulationto a user's skin, wherein the applicator surface comprises an outletopening, and wherein the dosing aid comprises a dose marking on theapplicator surface, wherein the dose marking has an outline that is atleast partially circular, the circular part of the outline having adiameter D, and wherein the dose marking circumscribes an inner dosingcompartment that serves to measure the predefined dose of the topicalformulation, and wherein the outlet opening is disposed inside the innerdosing compartment, wherein the diameter D is selected such that, whenthe topical formulation is ejected from the outlet opening, the amountof topical formulation that spreads from the outlet opening and over theinner dosing compartment until it reaches the dose marking, correspondsto the predefined dose, wherein the dose marking is a visual dosemarking, wherein the dose marking is realized on the applicator surfaceby surface treatment of the applicator surface, application of colormarkings on the applicator surface, by producing the applicator surfacefrom several materials, wherein a border between two distinct materialsserves as the dose marking, or by moulding-in of the dose marking intothe applicator surface, wherein the dose marking has a color that isdifferent from the color of a rest of the applicator surface, andwherein the dosing aid is adapted for dosing of two predefined doses oftopical formulation.

This disclosure also provides an applicator head for administration of atopical formulation, comprising a dosing aid for application of apredefined dose of the topical formulation, wherein the applicator headcomprises an applicator surface adapted to apply the topical formulationto a user's skin, wherein the applicator surface comprises an outletopening, and wherein the dosing aid comprises a dose marking on theapplicator surface, wherein the dose marking has an outline that is atleast partially circular, the circular part of the outline having adiameter D, and wherein the dose marking circumscribes an inner dosingcompartment that serves to measure the predefined dose of the topicalformulation, and wherein the outlet opening is disposed inside the innerdosing compartment, wherein the diameter D is selected such that, whenthe topical formulation is ejected from the outlet opening, the amountof topical formulation that spreads from the outlet opening and over theinner dosing compartment until it reaches the dose marking, correspondsto the predefined dose, wherein the dose marking is a visual dosemarking, wherein the dose marking is realized on the applicator surfaceby surface treatment of the applicator surface, application of colormarkings on the applicator surface, by producing the applicator surfacefrom several materials, wherein a border between two distinct materialsserves as the dose marking, or by moulding-in of the dose marking intothe applicator surface, wherein the dose marking has a color that isdifferent from the color of a rest of the applicator surface, whereinthe dosing aid is adapted for dosing of two predefined doses of topicalformulation, wherein there is more than one dose marking on theapplicator surface, and wherein the dose markings are arranged on theapplicator surface concentrically around the outlet opening.

This disclosure also provides an applicator head for administration of atopical formulation, comprising a dosing aid for application of apredefined dose of the topical formulation, wherein the applicator headcomprises an applicator surface adapted to apply the topical formulationto a user's skin, wherein the applicator surface comprises an outletopening, and wherein the dosing aid comprises a dose marking on theapplicator surface, wherein the dose marking has an outline that is atleast partially circular, the circular part of the outline having adiameter D, and wherein the dose marking circumscribes an inner dosingcompartment that serves to measure the predefined dose of the topicalformulation, and wherein the outlet opening is disposed inside the innerdosing compartment, wherein the diameter D is selected such that, whenthe topical formulation is ejected from the outlet opening, the amountof topical formulation that spreads from the outlet opening and over theinner dosing compartment until it reaches the dose marking, correspondsto the predefined dose, wherein the dose marking is a visual dosemarking, wherein the dose marking is realized on the applicator surfaceby surface treatment of the applicator surface, application of colormarkings on the applicator surface, by producing the applicator surfacefrom several materials, wherein a border between two distinct materialsserves as the dose marking, or by moulding-in of the dose marking intothe applicator surface, wherein the dose marking has a color that isdifferent from the color of a rest of the applicator surface, whereinthe dosing aid is adapted for dosing of two predefined doses of topicalformulation, wherein there is more than one dose marking on theapplicator surface, wherein the dose markings are arranged on theapplicator surface concentrically around the outlet opening, and whereinthere are a first and a second dose marking on the applicator surface,wherein the first dose marking is arranged between the outlet openingand the second dose marking, and wherein the first and second dosemarking between them circumscribe a ring dosing compartment, and whereinthe ring dosing compartment has a ring width W that is the distancebetween the first and the second dose marking.

This disclosure also provides an applicator head for administration of atopical formulation, comprising a dosing aid for application of apredefined dose of the topical formulation, wherein the applicator headcomprises an applicator surface adapted to apply the topical formulationto a user's skin, wherein the applicator surface comprises an outletopening, and wherein the dosing aid comprises a dose marking on theapplicator surface, wherein the dose marking has an outline that is atleast partially circular, the circular part of the outline having adiameter D, and wherein the dose marking circumscribes an inner dosingcompartment that serves to measure the predefined dose of the topicalformulation, and wherein the outlet opening is disposed inside the innerdosing compartment, wherein the diameter D is selected such that, whenthe topical formulation is ejected from the outlet opening, the amountof topical formulation that spreads from the outlet opening and over theinner dosing compartment until it reaches the dose marking, correspondsto the predefined dose, wherein the dose marking is a visual dosemarking, wherein the dose marking is realized on the applicator surfaceby surface treatment of the applicator surface, application of colormarkings on the applicator surface, by producing the applicator surfacefrom several materials, wherein a border between two distinct materialsserves as the dose marking, or by moulding-in of the dose marking intothe applicator surface, wherein the dose marking has a color that isdifferent from the color of a rest of the applicator surface, whereinthe dosing aid is adapted for dosing of two predefined doses of topicalformulation, and wherein there is more than one dose marking on theapplicator surface, wherein the dose markings are arranged on theapplicator surface concentrically around the outlet opening, and whereinthere are a first and a second dose marking on the applicator surface,wherein the first dose marking is arranged between the outlet openingand the second dose marking, and wherein the first and second dosemarking between them circumscribe a ring dosing compartment, wherein thering dosing compartment has a ring width W that is the distance betweenthe first and the second dose marking, and wherein the ring width W isselected such that when the topical formulation is ejected from theoutlet opening, the amount of topical formulation that spreads from theoutlet opening and over the inner dosing compartment and further overthe ring dosing compartment, until it reaches the second dose marking,corresponds to a second predefined dose.

DESCRIPTION OF DRAWINGS/FIGURES

FIG. 1 shows a top view of a first embodiment of an applicator head withdosing aid.

FIG. 2 shows a top view of a second embodiment of an applicator headwith dosing aid.

FIG. 3 shows an exploded perspective side view of an applicator surfaceof the embodiment of FIG. 2.

FIG. 4 shows a top view of a third embodiment of an applicator head withdosing aid.

FIG. 5 shows an exploded perspective side view of an applicator surfaceof the embodiment of FIG. 4.

FIG. 6 shows a central vertical cut view of an applicator surface of theembodiment of FIG. 2.

FIG. 7 shows a side view of the embodiment of FIG. 2.

FIG. 8 shows a perspective external view of the embodiment of FIG. 2.

FIG. 9 shows a perspective view of a fourth embodiment.

FIG. 10 shows a perspective view of a packaging comprising the head ofthe embodiment of FIG. 9.

FIG. 11 shows a side view of the head of the embodiment of FIG. 9.

FIG. 12 shows a top view of the head of the embodiment of FIG. 9.

DETAILED DESCRIPTION

FIGS. 1-12 illustrate an applicator head (10) according to embodimentsof the present invention. The present invention is directed to anapplicator head (10) comprising an applicator surface (20) having adosing aid. The dosing aid is suitable for measuring a predefined doseof a topical formulation. The dosing aid comprises a dose marking (60),and in some embodiments multiple dose markings (60′, 62′, 60″, 62″). Thedose markings (60, 60′, 60″, 62′, 62″) are formed on the applicatorsurface (20).

Applicator Head

The present disclosure provides for an applicator head (10) comprisingan applicator surface (20). The applicator head (10) can be mounted ontoa container or connected to a container, for example a tube or a can.Alternatively, the applicator head (10) can be formed in one piece witha container.

The applicator surface (20) is preferably substantially flat. Theapplicator surface (20) may be formed in one piece with the applicatorhead (10) or may be a separate piece, connectable to an applicator headbody (11). The applicator surface (20) comprises a bottom side facingthe applicator head body (11). Opposite the bottom side, the applicatorsurface (20) has an upper side, facing outwards, or facing a user.

The applicator surface (20) can be laterally limited by an end wall(30). The end wall (30) can extend from the bottom side of theapplicator surface (20). Preferably, the applicator surface (20) issubstantially circular. A circular applicator surface (20) provides thebest results in terms of product distribution and sensation uponapplication of topical formulation to skin. Circular form of theapplicator surface (20) is especially preferred for applicator headsused for massaging, as the circular form does not have edges which couldpinch or scratch when pressed onto skin with massage pressure. Theapplicator surface (20) is adapted for application of a topicalformulation on a user's skin. A user can thus use the applicator head(10) instead of his or her hands to apply a topical formulation.Thereby, the user's hands are kept clean. For example, the applicatorsurface (20) can be adapted for rubbing or massaging of a topical skincream into a user's skin. Alternatively, a user can wipe the topicalformulation from the applicator surface (20) with his or her hand, andthen manually apply the topical formulation to desired body parts.

This means in particular that the applicator surface (20) has a smoothupper surface without sharp edges or similar surface structures whichcould cause an unpleasant sensation. Such a smooth surface also ensuresthat the topical formulation, skin scales or the like cannot accumulateon the applicator surface (20). A smooth surface also provides skinfriendly haptics. A smooth upper surface is furthermore preferred as itenables topical formulation to spread uniformly across the applicatorsurface (20).

The applicator surface (20) can be made from a plastic material. Plasticmaterial provides a strength suitable to use the applicator surface (20)for massaging. Alternatively, the applicator surface (20) may be from asponge or fabric material. The sponge or fabric material can partiallyabsorb the topical formulation and release the formulation when theapplicator surface (20) is pressed onto the skin. Applicator surfaces(20) made from sponge or fabric material provide a soft and gentleapplication experience and reduce the risk of dripping of topicalformulation.

The applicator surface (20) can be flat or can comprise surfaceundulations (80). Surface undulations (80) are protrusions of theapplicator surface (20) that protrude from the upper side. An example ofsurface undulations (80) are massage bumps. Surface undulations (80)provide a massaging effect when the applicator head (20) is used toapply a topical formulation. Due to surface undulations (80), theapplicator surface (20) can have a wavy or rippled surface profile. In apreferred embodiment, the applicator surface (20) comprises surfaceundulations (80) which are rounded. Rounded surface undulations (80) arepreferred to avoid ridges or edges on the applicator surface (20).Surface undulations (80) preferably protrude from the applicator surface(20) from about 0.5 mm to about 1.0 mm. Surface undulations (80) of thisheight of protrusion provide a massaging effect whilst not hinderinguniform spread of topical formulation across the applicator surface(20).

In another embodiment, the applicator surface (2) can also comprisedifferent portions. In another embodiment, the applicator surface (2)comprises a horizontal portion (21) and a slanting portion (22). Theslanting portion (22) is angled in relation to the horizontal portion(21) and forms a sloping edge of the applicator head (20). The slantingportion (21) can form about 20% to 60%, about 30% to 50%, preferablyabout 40% of the applicator surface (2).

Within the applicator surface (20) there is formed at least one outletopening (40). The outlet opening (40) is a hole in the applicatorsurface (20). Preferably, the outlet opening (40) is circular. Circularoutlet openings (40) form uniformly thick, round lines of topicalformulation, which is beneficial for uniformity of dosing. There may beone single outlet opening (40) or there may be multiple outlet openingsarranged on the applicator surface (20). In embodiments with multipleoutlet openings (40), the outlet openings (40) preferably are disposedon the applicator surface (20) point symmetrical. For example, there maybe formed from about five to about eleven outlet openings (40) formed onthe applicator surface (20), arranged in a circle of outlet openings.

In embodiments with one outlet opening (40), the outlet opening (40)preferably has a diameter of about 2.5 mm to about 5 mm. Diameters ofthis range are suitable for easy expulsion of most topical formulationswith their typical viscosity and flow characteristics. Diameters of thisrange are at the same time suitable for precise expulsion, especially ofsmall doses of topical formulation, such as 2 grams. The outlet opening(40) can communicate with a flow conduit which is formed inside theapplicator head. When the applicator head (10) is connected to acontainer comprising topical formulation, the flow conduit connects aninside of the container to the outside. Topical formulation can thus beurged out of the container, through the flow conduit and out of theoutlet opening (40). Upon expulsion, topical formulation can flowthrough the applicator head (10) in a flow direction A-A′. In someembodiments, the applicator surface (20) is arranged perpendiculartowards the flow direction A-A′. In other embodiments, the applicatorsurface (20) is arranged in a uniform acute angle towards the flowdirection A-A′. These perpendicular and acute angle arrangements of theapplicator surface (20) are preferred because they result in laminarflow of topical formulation and reliable uniform spread of topicalformulation on the applicator surface (20). In other embodiments, ahorizontal portion (21) of the applicator surface (20) is arrangedperpendicular to the flow direction A-A′, and a slanting portion (22) ofthe applicator surface (20) is arranged in an angle of less than 180°towards the flow direction A-A′.

The applicator surface (20) can optionally comprise an outlet rim (50).The outlet rim (50) borders the outlet opening (40). The outlet rim (50)is an annular protrusion protruding from the applicator surface (20).The outlet rim (50) has the outlet opening (40) in its center. Theoutlet rim (50) can protrude from the applicator surface (20) about 1 mmto about 2 mm above a level at which it merges with the applicatorsurface (20). The outlet rim (50) can aid uniform, circular spread oftopical formulation across the applicator surface (20).

In some embodiments, the applicator surface (20) can have a curvature.Preferably, the applicator surface (20) has a curvature, the curvaturebeing spheroidal convex from the outlet opening (40) to the end wall(30). The highest point of the curvature can be close to the outletopening (40) and the lowest point of the curvature can be near the endwall (30). In one embodiment, the height difference between the highestpoint of the curvature and the lowest point of the curvature is about0.75 mm to about 2 mm. This convex curvature in the applicator surface(20) facilitates application and massaging. It also facilitates spreadof product on the applicator surface (20), by gravity. This isespecially preferred for topical formulations with a viscosity of 1.5Pa·s or higher.

In embodiments with circular applicator surfaces (20), the outletopening (40) preferably is formed centrally on the applicator surface(20). This is preferred because thereby, a user can intuitively spot theoutlet opening (40) on the applicator surface (20). It is also preferredbecause thereby, outlet opening (40), applicator surface (20) and adosing aid comprising dose markings (60, 60′, 60″, 62′, 62″), can bearranged concentrically to the outlet opening (40). Concentricarrangement facilitates understanding of the dosing aid.

In embodiments where the applicator surface (20) is arranged in auniform acute angle towards the flow direction A-A′, the outlet opening(40) can preferably be arranged marginally of the applicator surface(2). By that, there is more surface of the applicator surface (2) thatthe topical formulation can spread over.

The applicator head (10) comprises a dosing aid. The dosing aid issuitable for measuring of a predefined dose of a topical formulation.The dosing aid comprises a dose marking (60), and in some embodimentsmultiple dose markings (60′, 62′, 60″, 62″). The dose markings (60, 60′,60″, 62′, 62″) are formed on the applicator surface (20). The dosemarkings (60, 60′, 60″, 62′, 62″) can have a partially circular outlineand a diameter D. In some embodiments, the outline of the dose markings(60, 60′, 60″, 62′, 62″) can be completely circular. In someembodiments, the outline of the dose markings (60, 60′, 60″, 62′, 62″)can be ellipsoid. The outline of the dose markings (60, 60′, 60″, 62′,62″), and the diameter D are adapted to a predefined dose of topicalformulation, to be measured with the dosing aid. Methods of adjustingoutline of the dose markings (60, 60′, 60″, 62′, 62″), and the diameterD to predefined doses of topical formulations are described in aseparate section below. The dose markings (60, 60′, 60″, 62′, 62″) canbe positioned on the applicator surface (20) with the outlet opening(40) in their center. In other words, the outlet opening (40) can bedisposed in the center of the circular outline of the dose markings (60,60′, 60″, 62′, 62″). In embodiments with two or more dose markings, thedose markings (60, 60′, 60″, 62′, 62″) have different diameters D andcan be arranged concentrically around the outlet opening (40). Inembodiments with multiple outlet openings (40), the outlet openings (40)can be disposed on the applicator surface (20) point symmetrical to acenter of the circular outline of the dose marking(s),In embodimentswith an irregular applicator surface (20), such as an applicator surface(20) comprising a horizontal portion (21) and a slanting portion (22),as described above, and in embodiments with an angled applicator surface(20), the dose marking(s) (60, 60′, 60″, 62′, 62″) are adapted to thoseirregularities. For example, the dose markings (60, 60′, 60″, 62′, 62″)can be circular with a uniform diameter Don the horizontal portion (21),and can be ellipsoid with a varying diameter D on the slanting portion(22). Methods of adjusting an outline of the dose marking(s) (60, 60′,60″, 62′, 62″) to irregularities of the applicator surface (20) aredescribed in a separate section below.

Two dose markings circumscribe between them a ring dosing compartment(66). Ring dosing compartments (66) can have ring widths W. Methods ofadjusting diameters D and ring widths W to first, second and furtherpredefined doses of topical formulation are described in a separatesection below.

The dose marking(s) (60, 60′, 60″, 62′, 62″) can be realized on theapplicator surface (20) in numerous ways. For example, the dose markings(60, 60′, 60″, 62′, 62″) can be realized by embossing, application ofcolor, imprinting, printing, molding-in, in-mold labelling, surfacetreatment, laser etching, laser engraving or stickering. The dosemarking(s) (60, 60′, 60″, 62′, 62″) can for example be haptic dosemarkings, visual dose markings, or a combination thereof. Preferably,the dose markings are visual dose markings. That means, the dosemarkings can be perceived visually by a user on the applicator surface(20). Visual dose markings are preferred as they are easily noticed andunderstood by most users. More preferably, the dose marking(s) (60, 60′,60″, 62′, 62″) are only visual dose markings. In other words, the dosemarking(s) (60, 60′, 60″, 62′, 62″) do not protrude from or incise inthe applicator surface (20), i.e., the dose markings do not alter asurface profile of the applicator surface (20). This is preferred asthereby the preferred smooth surface of the applicator surface (20) canbe maintained, and massaging and ease of application with the applicatorhead (10) is not hampered by the dose marking(s) (60, 60′, 60″, 62′,62″).

Furthermore, provided the topical formulation has a suitable viscosity,dose markings (60, 60′, 60″, 62′, 62″) which are only visual dosemarkings lead to more precise dosing results, whereas a dose markingprotruding from the applicator surface could for example lead to anaccumulation of product in the region of the applicator head (20′)inwards of the respective dose marking (60, 60′, 60″, 62′, 62″), forexample an inner dosing compartment (64), and thus to a quantity oftopical formulation not being well defined.

In embodiments with visual dose markings, it is preferred that thedosing compartment or dosing compartments, the dose marking or dosemarkings (60, 60′, 60″, 62′, 62″), or both, differ from a rest of theapplicator surface (20) in color. Preferably, colors are chosen thatdiffer strongly, such that a demarcation between different colors isreadily apparent. In some embodiments, a rest of the applicator surface(20) has a color similar to a color of the topical formulation to bedosed with the applicator head (10), and the dose marking(s) (60, 60′,60″, 62′, 62″) have a different color. This facilitates dosing with theapplicator head, as it can instantaneously be seen when the topicalformulation covers a dosing compartment or reaches a dose marking.Preferably, to create a high contrast, the colors should be as apart aspossible on a color wheel, such as light and dark shades. Also preferredare primary colors, or colors close to primary colors. In oneembodiment, the dose marking(s) (60, 60′, 60″, 62′, 62″) have an orangecolor and a rest of the applicator surface (20) has a white color.Orange and white color are especially preferred, as they have a highcontrast, and as most topical formulations are opaque to white. Thisfacilitates dosing with the applicator head (10).

The dose marking(s) (60, 60′, 60″, 62′, 62″) can be standalone features,such as lines, broken lines or rings. Alternatively, a demarcationbetween areas on the applicator surface (20) that have differentcharacteristics can serve as the dose marking or dose markings. Forexample, a line of demarcation between two differently coloredcompartments of the applicator surface (20) can constitute a dosemarking.

In embodiments comprising one dose marking (60), the dose marking (60)circumscribes an inner dosing compartment (64) on the applicator surface(20). A remaining area of the applicator surface (20) is an outercompartment (68). Outer compartment (68) is not used for dosing. Theinner dosing compartment (64) serves to measure one predefined dose oftopical formulation. Methods of dosing with the applicator head (10)comprising one dose marking (60) are described in a separate sectionbelow.

In embodiments comprising more than one dose marking (60′, 60″, 62′,62″), a first or innermost dose marking (60′, 60″), i.e., the dosemarking with the smallest diameter D, circumscribes the inner dosingcompartment (64). The inner dosing compartment (64) serves to measure afirst predefined dose of topical formulation. A second dose marking(62′, 62″) is a dose marking with the second smallest diameter D. Firstand second dose marking (60′, 60″, 62′, 62″) between them circumscribe afirst ring dosing compartment (66). A first ring dosing compartment (66)is an area on the applicator surface (20) that is delimited inwardly bya first dose marking (60′, 60″) and delimited outwardly by a second dosemarking (62′. 62″). The ring dosing compartment (66) can have a ringwidth W. The ring dosing compartment (66), together with the innerdosing compartment (64), serves to measure a second predefined dose oftopical formulation. A remaining area of the applicator surface, i.e.,outwardly from the second dose marking (62′, 62″), is an outercompartment (68).

The applicator head (10) can comprise a third dose marking and furtherdose markings, all dose markings being arranged concentrically and eachdose marking having a wider diameter D than the previous dose marking.The same applies in analogy to embodiments comprising an irregularapplicator surface (20). The dose markings can be arranged withincreasing width of their outlines, seen from the outlet opening (40).Multiple dose markings circumscribe multiple ring dosing compartments,analogous to what was described above for two dose markings. Methods ofdosing with the applicator head comprising two or more dose markings aredescribed in a separate section below.

The dose markings (60, 60′, 60″, 62′, 62″) divide the applicator surface(20) into compartments. Embodiments comprising one dose marking (60)comprise one dosing compartment (64), suitable to measure one predefineddose of topical formulation. Embodiments comprising two dose markings(60′, 60″, 62′, 62″) comprise two dosing compartments (64, 66), suitableto measure two predefined doses of topical formulation, etc. An areaoutwardly from an outermost dose marking is an outer compartment (68),which is not used for dosing. When topical formulation is urged out ofthe outlet opening (40), the topical formulation spreads evenly in acircular formation filling the dosing compartment(s) (64, 66). Inembodiments with an irregular or angled applicator surface (20), thetopical formulation can spread irregularly. However, the dose marking(s)(60, 60′, 60″, 62′, 62″) are adapted to such irregular spread. The dosemarking(s) (60, 60′, 60″, 62′, 62″) have an outline that accommodatesthe predefined dose(s) of the topical formulation.

In some embodiments, the inner dosing compartment (64) has a differentcolor than the outer compartment (68). In some embodiments, theapplicator surface (20) is molded from multiple materials, and bordersbetween the materials constitute the dose marking (60) or dose markings(60′, 60″, 62′, 62″). The materials can be the same or distinct plasticmaterials, such as HDPE, LDPE, Poly Propylene, Poly Carbonate orSilicon. Preferred is HDPE. Preferably, the materials differ in color.

In another embodiment, the dose marking (60) or dose markings (60′, 60″,62′, 62″) are laser etched circular lines on the applicator surface(20). The lines can be continuous or can be broken lines.

In one embodiment, the applicator surface (20) comprises a ring (65).The ring (65) can be molded into the applicator surface (20) bybi-injection molding, which is a technique known in the art. Forexample, a body of the applicator surface (20) can be molded from afirst material in a first molding step. In this first molding step, anannular recess (67) is foreseen in the body. The recess may be about0.75 mm to about 1.5 mm deep from the applicator surface (20). Preferredis a recess of about 0.9 mm deep from the applicator surface (20). In asecond molding step, this recess (67) can be filled with a secondmaterial of the ring (65). Preferably, the first and second material areboth HDPE materials, but differ in color. The amount of second materialinjected to form the ring (65) is sufficient to fill the recess (67).Preferably, ring (65) does not project from the applicator surface (20)after cooling. Preferably, ring (65) recesses from the applicatorsurface (20) by less than about 0.2 mm. In some embodiments, margins ofring (65) flush with margins of recess (67). The ring (65) has an innerdiameter D, a ring width W and a thickness T. The outlet opening (40) ispositioned in the center of the ring (65). An inner line of demarcation,or inner border, between the first material of the applicator surfacebody and the second material of the ring (65) constitutes a first dosemarking (60′). An outer line of demarcation, or outer border, betweenthe second material of the ring (65) and the first material of theapplicator surface body constitutes a second dose marking (62′). Thefirst dose marking (60′) has a diameter D, which is the same as theinner ring diameter D, and which is about 20 mm to about 26 mm. Thesecond dose marking (62′) has a diameter of about 23 mm to about 29 mm,which is the sum of diameter D and ring width W. The ring (65) dividesthe applicator surface (20) into an inner dosing compartment (64), aring dosing compartment (66), and an outer compartment (68). Thediameters of the first and second dose marking (60′, 62′) are adaptedsuch that the inner dosing compartment (64) can accommodate a predefinedfirst dose of a particular topical formulation, and the inner dosingcompartment (64) together with the ring dosing compartment (66) canaccommodate a predefined second, higher dose of a particular topicalformulation. Methods of dosing are described in a separate sectionbelow. FIG. 2 and FIG. 3 show such an embodiment, described in moredetail below. The foregoing applies in analogy to embodiments comprisingan irregular applicator surface (20). The shape, size and position ofthe ring on the applicator surface (2) in such cases can be adapted totake into account the design of the applicator surface. Methods ofdetermining an outline of the dose marking(s) (60, 60′, 60″, 62′, 62″)for such embodiments are described in a separate section below.

In another preferred embodiment, the applicator surface (20) comprisestwo rings. Preferably there are a first and a second ring on theapplicator surface. Preferably, the first ring constitutes a first dosemarking (60″), and the second ring constitutes a second dose marking(62″). The first dose marking (60″) is arranged between the outletopening (40) and the second dose marking (62″). In this embodiment, thefirst and second dose markings (60″, 62″) between them circumscribe aring dosing compartment (66). First dose marking (60″) has an innerdiameter D, and an outer diameter. Second dose marking (62″) has aninner diameter D1, and an outer diameter. Preferably, D is about toabout 19 mm to 21 mm, and D1 is about to about 25 mm to 27 mm. In oneembodiment, the thickness of the rings is from about 0.5 mm to about 0.9mm. Preferably, the rings are about 0.9 mm thick, that is the differencebetween the outer diameter and the inner diameter (D, D1) is about 0.9mm. The ring dosing compartment has a ring width W which determined bythe difference between the inner diameter D1 of the second dose marking(62″) and the outer diameter of the first dose marking (60″).Preferably, the first and second dose markings (60″, 62″) are moldedinto the applicator surface (20). Preferably, the first and second dosemarkings (60″, 62″) have a different color than a rest of the applicatorsurface (20). This can be achieved by bi-injection molding techniquesknown in the art. For example, the applicator surface (20) can be moldedfrom HDPE, wherein HDPE of a first color is used for molding of theapplicator surface (20), and wherein HDPE of a second color is used formolding of the dose markings (60″, 62″). In a first molding step, a bodyof the applicator surface can be molded from the first material. Twoannular recesses (67) can be foreseen on the upper side of theapplicator surface (20). The recesses (67) can be about 0.75 mm to about1.5 mm deep. In a second molding step, the recesses (67) can be filledwith the second material to form the two rings or dose markings (60″,62″). The amount of material injected into the two annular recesses (67)is sufficient to fill said recesses (67). The two dose markings (60″,62″) thus are rings of the second material molded into the applicatorsurface (20). After cooling, preferably the dose markings (60″, 62″)recess from the applicator surface by less than 0.2 mm. Preferably,after cooling the dose markings (60″, 62″) flush with the applicatorsurface (20). In other words, the dose markings (60″, 62″) do not altera surface profile of the applicator surface (20). The first and seconddose markings (60″, 62″) stand out from the applicator surface (20) asthey have a different color. Methods of adjusting inner and outerdiameters of the dose markings (60″, 62″) to predefined doses of topicalformulations are described in a separate section below. Methods ofdosing with such embodiments are described in a separate section below.FIG. 4 and FIG. 5 show an example of such an embodiment with two rings,and are described in more detail below.

The foregoing applies in analogy to embodiments comprising an irregularapplicator surface (20). The shape, size and position of the rings onthe applicator surface (2) in such cases can be adapted to take intoaccount the design of the applicator surface. Methods of determining asuitable outline of the dose marking(s) (60, 60′, 60″, 62′, 62″) forsuch embodiments are described in a separate section below.

In some embodiments, the dose markings (60, 60′, 60″, 62′, 62″) furthercomprise a dose indicator or dose indicators (61, 63). Dose indicators(61, 63) can comprise symbols, such as a figure or a letter, thatconstitute a clue to a dose. For example, if a dose marking (60, 60′,60″) is adapted to measuring a first predefined dose, for example 2grams, a dose indicator (61) can be a figure “2”, present on theapplicator surface (20), in association with the dose marking (60, 60′,60″). In embodiments with two or more dose markings (60, 60′, 60″, 62′,62″), there can be two or more corresponding dose indicators (61, 63).Like the dose markings (60, 60′, 60″, 62′, 62″), the dose indicators(61, 63) can be realized on the applicator surface (20) in numerousways. For example, the dose indicators (61, 63) can be imprinted,embossed, printed, or they can be realized by surface finish by etchingor laser etching. In embodiments with dose marking or dose markings (60,60′, 60″, 62′, 62″) produced by bi-injection molding, it is preferredthat the dose indicator or dose indicators (61, 63) are produced in thesame bi-injection molding step. In a preferred embodiment, theapplicator surface (20) is realized by bi-injection molding, whereby theapplicator surface (20) and symbols of the dose indicator(s) (61, 63)are molded from a first material, and the dose marking(s) (60, 60′, 60″,62′, 62″) and an area surrounding the symbols of the dose indicator(s)(61, 63) are molded form a second material. Preferably, in thoseembodiments, the first and second material have different colors.Thereby, an applicator surface (20) comprising dose marking(s) (60, 60′,60″, 62′, 62″) and dose indicator(s) (61, 63) can be produced within asingle bi-injection molding process, wherein the dose indicators (61,63) are clearly visible.

The applicator head (10) can further comprise a cap (100) and anopen-and-closing mechanism. The applicator head (10) can be connected toa container for topical formulations. In some embodiments, the containercan be a tube. The applicator head (10) can therefore comprise means(32, 76, 90) for attaching the applicator head to the container.

Adaption of Dimensions of the Dose Markings and Manufacturing

The diameter(s) D, D1 and the outline of the dose marking(s) (60, 60′,60″, 62′, 62″), and ring width(s) W can be adapted to predefined dosesas described below.

To adapt the diameter D of a single dose marking (60) to a single doseof a topical formulation, a prototype of an applicator head (10) with adose marking (60) of a prototype-diameter is provided. The prototypeapplicator head is connected to a container, the container containingthe topical formulation to be dosed. Thecontainer-applicator-head-combination is weighed. Then, the container isheld in upright position, i.e., such that the applicator surface (20) issubstantially horizontal. Topical formulation is ejected from the outletopening (40), until it spreads over the applicator surface (20) andreaches the dose marking (60). The ejected topical formulation is thenremoved from the applicator surface (20). Thecontainer-applicator-head-combination is weighed a second time. Thedifference between the first and second weight corresponds to theejected amount, or dose, of topical formulation. If the ejected dose islower than the predefined dose, in a second prototype, diameter D isincreased. If the ejected dose is higher than the predefined dose, in asecond prototype, diameter D is decreased. The described steps arerepeated until an ejected dose corresponds to the predefined dose.

To adapt diameters D of first, second, and further dose markings (60′,60″, 62′, 62″) to first, second and further predefined doses, the abovesteps are carried out for all dose markings and doses subsequently,starting form the first dose marking (60′, 60″), i.e. the dose markingwith the smallest diameter D. Ring width(s) W logically follow from thediameters D of the dose markings (60′, 60″, 62′, 62″).

The skilled artisan can thereby adapt diameters D to a topicalformulation and predefined doses. The adequate outline of dosemarking(s) (60, 60′, 60″, 62′, 62″), e.g. for applicator heads (10) withangled or irregular applicator surfaces (20) can be determinedsimilarly: A prototype of an applicator head (10) with a dose marking(s)(60, 60′, 60″, 62′, 62″) of a prototype-outline such as a circularoutline is provided. The prototype applicator head is connected to acontainer, the container containing the topical formulation to be dosed.The container-applicator-head-combination is weighed. Then, thecontainer is held in a dosing position, such as a position in which theflow direction A-A′ is perpendicular to the floor.

Topical formulation is ejected from the outlet opening (40), until itspreads over the applicator surface (20) and reaches the dose marking(s)(60, 60′, 60″, 62′, 62″). The form in which the topical formulationspreads over the applicator surface (20) is registered, e.g. byphotography. The ejected topical formulation is then removed from theapplicator surface (20). The container-applicator-head-combination isweighed a second time. The difference between the first and secondweight corresponds to the ejected amount, or dose, of topicalformulation. If the ejected dose is lower than the predefined dose, in asecond prototype, the outline of the dose marking(s) (60, 60′, 60″, 62′,62″) is enlarged. If the ejected dose is higher than the predefineddose, in a second prototype, the outline of the dose marking(s) (60,60′, 60″, 62′, 62″) is scaled down. In addition, the outline is changedto resemble more closely the shape in which the topical formulationspreads over the applicator surface (20). The described steps arerepeated until an ejected dose corresponds to the predefined dose andthe dose marking(s) (60, 60′, 60″, 62′, 62″) have the adequate outlinethat precisely traces the shape in which the topical formulation willspread.

The applicator heads disclosed herein are especially suitable fortopical formulations with a viscosity of about 1 Pa·s to 4 Pa·s, morepreferred 1.5 Pa·s to 3.5 Pa·s.

Manufacturing

The applicator head (10) can be molded from plastic material in a singlematerial of any color, preferably white, by an injection moldingprocess. The dose marking(s) (60′, 60″, 62′, 62″), and optionally doseindicators (61, 63), can be realized during the molding process bysurface finish difference. For example, dose markings (60′, 60″, 62′,62″), and optionally dose indicators (61, 63), can be realized in a mattsurface finish, whilst the applicator surface (20) surrounding the dosemarking(s) (60′, 60″, 62′, 62″) and dose indicators (61, 63) have aglossy surface finish.

Alternatively, the dose marking(s) (60, 60′, 60″, 62′, 62″) can also beembossed onto the applicator surface (20). Preferably, the embossingerects by about 0.25 mm to about 0.75 mm from the applicator surface(20) to create the contrast.

In again another alternative, the dose marking(s) (60′, 60″, 62′, 62″),and optionally dose indicators (61, 63), are realized on the applicatorsurface (20) in a different color than the applicator surface (20). Forexample, the dose marking(s) (60, 60′, 60″, 62′, 62″), and optionallydose indicators (61, 63) are realized on the applicator surface (20) byprinting, laser engraving or stickering.

For laser etching, the applicator head (10) is loaded onto a laseretching machine. A laser beam follows a preferred path to burn thematerial in indicated areas on the applicator surface (20) to create thedose marking(s) (60, 60′, 60″, 62′, 62″), and optionally dose indicators(61, 63). This results in the treated areas to be of a different shadeof a base color of the applicator surface (20). For example, when theapplicator surface (20) is made from a white plastic material, treatmentwith the laser will yield grey dose marking(s) (60, 60′, 60″, 62′, 62″)and optionally dose indicators (61, 63).

A preferred method of manufacturing is manufacturing by bi-injectionmolding. In a first molding step or shot, a body of the applicatorsurface (20) can be molded from a first material. In this first moldingstep or shot, an annular recess (67) is foreseen in the body.Optionally, additional recesses are foreseen for the dose indicators(61, 63). Material is let cool but not ejected from the mold.Subsequently, in a second molding step or shot, recesses are filled witha second material. Preferably, the first and second material are bothHDPE materials that differ in color.

Product

There is also provided a packaging for a topical formulation comprisingan applicator head as described herein. The packaging comprises acontainer and an applicator head (10) as described herein, wherein theapplicator head (10) is connected to the container or wherein theapplicator head (10) is formed in one piece with the container. In oneembodiment, the container is a tube. There is also provided a product,comprising the packaging described herein, and a topical formulation inthat packaging. There is also provided a product as described herein,wherein the topical formulation has a viscosity in the range of 1 Pa·sto 4 Pa·s, preferably 1.5 Pa·s to 3.5 Pa·s.

Method

There is also provided a method of dosing of a topical formulation. Themethod of dosing a first or single predefined dose comprises thefollowing steps:

-   -   Holding a package of topical formulation, the package comprising        an applicator head (10), the applicator head comprising an        applicator surface (20) comprising a dose marking (60, 60′, 60″)        as described herein, in upright position, such that a flow        direction A-A′ is perpendicular to the floor;    -   Urging topical formulation from the package and out of an outlet        opening (40) in the applicator surface (20);    -   Letting the topical formulation spread over the applicator        surface (20), until it covers an inner dosing compartment (64);    -   Stopping urging of topical formulation as soon as the topical        formulation covers the inner dosing compartment (64) and before        it spreads further beyond the dose marking (60, 60′, 60″).

The amount of product on the applicator surface (20) corresponds to thefirst or single predefined dose.

There is also provided a method of dosing a first, second, or further,predefined dose, the method comprising the following steps:

-   -   Holding a package of topical formulation, the package comprising        an applicator head (10), the applicator head comprising an        applicator surface (20) comprising two or more dose markings        (60′, 60″, 62′, 62″) as described herein, in upright position,        such that a flow direction A-A′ is perpendicular to the floor;    -   Urging topical formulation from the package and out of an outlet        opening (40) in the applicator surface (20);    -   Letting the topical formulation spread over the applicator        surface (20), until it covers an inner dosing compartment (64);    -   If a first predefined dose is to be measured, stopping urging of        topical formulation as soon as the topical formulation covers        the inner dosing compartment (64) and before it spreads further        beyond a first dose marking (60′, 60″);    -   If a second predefined dose is to be measured, continuing urging        of topical formulation until the product covers the inner dosing        compartment (64) and a ring dosing compartment (66), and        stopping urging before the topical formulation spreads further        beyond a second dose marking (62′, 62″);    -   If a further predefined dose is to be measured, continuing        urging of topical formulation until the product covers the inner        dosing compartment (64), the ring dosing department (66) and        further dosing departments, and stopping urging before the        topical formulation spreads further beyond a further dose        marking, the further dose marking delimitating a desired dosing        compartment.

Preferably, dosing with the dosing aid as described herein achieves adosing accuracy of +/−10% (wt.).

Exemplary Embodiments

In FIG. 1, FIG. 2, FIG. 4 and FIG. 9, four different embodiments of anapplicator head (10) with a dosing aid are shown. The three embodimentsdiffer in the design of the applicator surface (20) and the elaborationof a dose marking (60) or dose markings (60′, 62′, 60″, 62″) on anapplicator surface (20).

FIG. 1, FIG. 2 and FIG. 4 show top views of applicator heads (10) foradministration of a topical formulation. The applicator head comprisesan applicator surface (20). In this top view, the other parts of theapplicator head (10) are not visible, as they are eclipsed by theapplicator surface (20). The applicator surface (20) is substantiallycircular. The applicator surface (20) is outwardly limited by an endwall (30). In an area close to the end wall (30), the applicator surface(20) falls away sharply to form a ridge (70). Ridge (70) is connected toan inclined section (72) of the end wall (30). The inclined section (72)of the end wall (30) merges into a vertical section (74) of the end wall(30) (shown e.g., in FIG. 3). Centrally in the substantially circularapplicator surface (20) is formed outlet opening (40). The outletopening (40) is a circular hole in the applicator surface (20). Theoutlet opening (40) has a diameter of about 5 mm. The outlet opening(40) is connected or connectable to a flow conduit, formed inside theapplicator head (10), and connects the flow conduit to the outside. Whenthe applicator head (10) is used with a package for topical formulation,the topical formulation can be urged through the flow conduit and out ofthe outlet opening (40). The outlet opening (40) is bordered by anoutlet rim (50). The outlet rim (50) is a substantially annularprotrusion, protruding from the applicator surface (20). The outlet rim(50) has an inner side facing the outlet opening (40). The inner sideslopes towards the outlet opening (40). From the sloping inner side,outlet rim (50) erects annularly to a highest level. An outer side ofoutlet rim (50) is slopes down from the highest level and meets theapplicator surface (20) in an obtuse angle. On the highest level,annular outlet rim (50) erects about 1 mm above a level at which itmerges with the applicator surface (20).

From the applicator surface (20) protrude surface undulations (80). Thesurface undulations (80) are bulbous elevations with a blunted,substantially hexagonal outline. The surface undulations (80) arearranged on the applicator surface (20) adjacent to each other, in theform of concentric rings of surface undulations (80), around the outletopening (40). Some surface undulations (80) have an equilateralhexagonal outline whilst other surface undulations (80) have unequalsided hexagonal outlines. The surface undulations (80) are arrangedseamlessly adjoining each other on the circular applicator surface (20).An outermost ring of surface undulations (80), that is a ring furthestremote from the outlet opening (40), is an incomplete ring with a gapevery fourth surface undulation (80). A majority of the applicatorsurface (20) is covered by surface undulations (80). A majority of theapplicator surface (20) therefore has a rippled, or wavy, surfaceprofile. An area adjacent to the outlet rim (50) and an area adjacent tothe end wall (30) do not have surface undulations (80). These areastherefore have an unrippled, or smooth, profile, and can be referred toas unrippled areas. Sides of surface undulations (80) adjacent tounrippled areas do not have the hexagonal outline, but have their edgesfacing the unrippled areas rounded.

The applicator surface (20) comprises a dosing aid. The dosing aidcomprises a dose marking (60) or dose markings (60′, 62′, 60″, 62″).

Referring to FIG. 1, an embodiment of the applicator head (10) is showncomprising one single dose marking (60). The dose marking (60) is asubstantially annular line on the applicator surface (20), with theoutlet opening (40) in its center. The line is about 0.5 mm thick. Thedose marking (60) divides the applicator surface (20) into an innerdosing compartment (64) and an outer compartment (68). In the embodimentof FIG. 1, the applicator surface (20) is made from HDPE and the dosemarking (60) is realized on the applicator surface (20) by laser etchingof the HDPE. Laser etching is a technique known in the art. Aftermolding, the applicator head (10) is loaded onto a laser etchingmachine. A laser beam follows a preferred path to burn the material inindicated areas on the applicator surface (20) to create the dosemarking (60). This results in the treated area to be of a differentshade of a base color of the applicator surface (20).

The dose marking (60) has a diameter D of about 20 mm. The diameter ofthe dose marking (60) is adapted such that the inner dosing compartment(64) can accommodate a predefined dose of a particular topicalformulation. Methods of adapting diameters of dose markings (60, 60′,60″, 62′, 62″) to predefined doses of topical formulations are describedabove in the detailed description. Methods of dosing with the dosemarking are also described above in the detailed description. For dosingof a topical formulation, e.g., a gel, a package comprising theapplicator head of FIG. 1 is held in an upright position. By upright itis meant that the applicator surface (20) is horizontal. The gel isurged out of the outlet opening (40) and spreads over the applicatorsurface (20). The gel forms a blob on the applicator surface (20). Whenthe blob covers the inner dosing compartment (64) and reaches the dosemarking (60), urging is stopped. An outer compartment (68) is free fromgel. The amount of gel that is now present on the applicator surface(20) corresponds to the predefined dose. In FIG. 1, diameter D isconfigured to accommodate about 2 grams of the product Voltarenarthritis pain.

FIG. 2 shows another embodiment of the applicator head (10). Theembodiment of FIG. 2 has the same features as the embodiment of FIG. 1,except for the elaboration of the dose markings (60′, 62′). In theembodiment of FIG. 2, the applicator head (10) is made from HDPE. A ring(65) is molded into the applicator surface (20) from the same HDPEmaterial, but in a different color. The ring (65) has the outlet opening(40) in its center. The ring (65) is molded into the applicator surface(20) by bi-injection molding, which is a technique known in the art. Thering (65) divides the applicator surface (20) into three sections: Aninner dosing compartment (64), a ring dosing compartment (66), and anouter compartment (68). A line of demarcation between the ring (65) andthe inner dosing compartment (64) constitutes a first dose marking(60′). A line of demarcation between the ring (65) and the outercompartment constitutes a second dose marking (62′). The ring (65) has aring width W of 6.0 mm, and a diameter D of 20.0 mm (shown in FIG. 3).Consequently, the first dose marking (60′) has the same diameter D of20.0 mm. The second dose marking (62′) has a diameter of 26.00 mm, whichis the sum of diameter D and ring width W. The diameters of the firstand second dose markings (60′, 62′) are adapted such that the innerdosing compartment (64) can accommodate a predefined first dose of aparticular topical formulation, and the inner dosing compartment (64)together with the ring dosing compartment (66) can accommodate apredefined second, higher dose of a particular topical formulation.Methods of adapting diameters of first and second dose markings (60′,62′) to predefined first and second doses of topical formulations aredescribed above in the detailed description. Dosing with the dosemarking of FIG. 2 is similar to the dosing described in the descriptionof FIG. 1, but the embodiment of FIG. 2 provides for measurement of twodifferent predefined doses. A first dose of topical formulation can bemeasured as described for FIG. 1 with the inner dosing compartment (64),and a second, higher dose of product can be measured as follows. Urgingis not stopped when the product reaches the inner dose marking (60′),but urging is continued until the product spreads further, surmounts thefirst dose marking (60′) and until the product covers the inner dosingcompartment (64) and the ring dosing compartment (66), and until itreaches the second dose marking (62′). When the product reaches thesecond dose marking (62′), urging is stopped. Outer compartment (68) isnot covered by product. The amount of product covering the inner dosingcompartment (64) and the ring dosing compartment (66) corresponds to apredefined second dose. In FIG. 2, diameter D and ring width W areconfigured such that the inner dosing compartment (64) accommodates 2grams of the product Voltaren arthritis pain and the dosing compartment(64) and the ring dosing compartment (66) together accommodate 4 gramsof the product Voltaren arthritis pain. The dosing accuracy achievedwith this embodiment is +/−10% (wt.).

FIG. 3 shows an exploded perspective side view of an applicator surface(20) of the embodiment of FIG. 2. Especially, ring (65) is shown removedfrom the applicator surface (20). This is for better understanding ofthe configuration and manufacturing only, as ring (65) is notnecessarily configured to be removed from the applicator surface (20).The applicator surface (20) of the embodiment of FIGS. 2, 3, 6 and 7 isproduced by bi-injection molding. In a first molding step, theapplicator surface (20) is molded from a first material in a firstcolor. A recess (67) is foreseen in the applicator surface (20) in thisfirst molding step. An arrangement of surface undulations (80) presenton the applicator surface (20) is continued on a ground of the recess(67). In a second molding step, this recess (67) is filled with a secondmaterial of the ring (66) which has a second color different from thefirst color. The amount of second material injected to form the ring(65) is sufficient to fill this recess (67). After cooling, ring (65)does not project from the applicator surface (20). Surface undulations(80) present on a surface of the ring (65) fit in seamlessly with anarrangement of surface undulations (80) on a remainder of the applicatorsurface (20). Ring (65) has a diameter D of 20.0 mm, a width W of 6.0 mmand a thickness T of 0.9 mm. FIG. 3 also shows plug (90) which serves toconnect the applicator surface (20) to remaining parts of the applicatorhead (10). Plug (90) is a tubular protrusion from a bottom side of theapplicator surface (20). It is disposed concentric around the outletopening (40). The plug (90) can accommodate parts of the applicator head(10) that form a flow channel for the topical formulation. Plug (90)protrudes tubularly from the bottom of the applicator surface (20) in astraight plug section (92). Straight plug section (92) is 9 mm long.Plug (90) ends slightly tapered in an inclined plug section (94). Theinclined plug section (94) provides easy assembly of the applicatorsurface (20) with remaining parts of the applicator head (10). Theapplicator surface (20) can be press-fitted onto remaining parts of theapplicator head (10).

FIG. 3 also shows flow direction A-A′. This flow direction A-A′indicates the direction in which a topical formulation, such as a gel orcream, flows, when the applicator surface of FIG. 3 is used with anapplicator head (10) for administration. The flow direction A-A′ runsthrough the plug (90) and through the outlet opening (40). FIG. 3 alsoshows that ridge (70) is connected to inclined section of end wall (72).Inclined section of end wall (72) merges into vertical section of endwall (74). Thereby, a blunted outer edge of applicator surface (20) isprovided. This provides for a smooth junction to remaining parts of theapplicator head (10). It also renders the haptics of the applicatorsurface (20) easy to the skin.

FIG. 4 shows yet another embodiment of the applicator head (10). Theembodiment of FIG. 4 has the same features as the embodiment of FIG. 1and FIG. 2, except that the elaboration of the dose markings (60″, 62″)is yet different. The embodiment of FIG. 4 comprises two rings as thetwo dose markings (60″, 62″), and additionally comprises dose indicators(61, 63).

Both dose markings (60″, 62″) are realized with rings, arrangedconcentrically around outlet opening (40). Like ring (65) in theembodiment of FIG. 2, the dose markings (60″, 62″) are molded into theapplicator surface (20). First dose marking (60″) is positioned closerto the outlet opening (40) and second dose marking (62″) is positionedfurther outwards from the outlet opening (40). In the embodiment of FIG.4, the applicator head (10) is made from HDPE and the first and seconddose markings (60″, 62″) are molded from the same material, but in adifferent color. The applicator surface (10) comprising the two dosemarkings (60″, 62″) is manufactured by bi-injection molding, a techniqueknown in the art. The first and second dose markings (60″, 62″) standout from the applicator surface (20) as they are colored differently.The dose markings (60″, 62″) additionally comprise dose indicators (61,63). The dose indicators (61, 63) are figures, formed withinsemi-circular bulges, the bulges being formed within dose marking rings(60″, 62″). In FIG. 3, dose indicators (61, 63) indicate the predefineddoses of 2 grams (61) and 4 grams (63) with the FIGS. “2” and “4”. Thefigures are from the same material and color as the applicator surface(20). Consequently, the figures stand out from the differently coloredbulges of the dose markings (60″, 62″), and are easily legible. Thefigure in the first dose indicator (61) of the first dose marking (60″)stands for a first predefined dose which can be measured with this firstdose marking (60″). The figure in the second dose indicator (63) of thesecond dose marking (62″) stands for a second predefined dose which canbe measured with the second dose marking (62″).

The two dose markings (60″, 62″) divide the applicator surface (20) intothree sections: An inner dosing compartment (64), a ring dosingcompartment (66), and an outer compartment (68). The ring dosingcompartment (66) in this embodiment is restricted by an outer margin ofthe first dose marking (60″) and an inner margin of the second dosemarking (62″). The ring dosing compartment (66) has a ring width W. Thefirst dose marking (60″) has an inner diameter D of 19.55 mm and anouter diameter of 20.45 mm (shown in FIG. 5). The second dose marking(62″) has an inner diameter D1 of 25.55 mm and an outer diameter of26.45 mm (shown in FIG. 5). The diameters of the first and second dosemarking (60″, 62″) are adapted such that the inner dosing compartment(64) can accommodate a predefined first dose of a particular topicalformulation, and the inner dosing compartment (64), together with thering dosing compartment (66) can accommodate a predefined second, higherdose of a particular topical formulation. Methods of adapting diametersof first and second dose markings (60″, 62″) to predefined first andsecond doses of topical formulations are described in the detaileddescription.

Dosing with the embodiment of FIG. 4 works as follows. A packagingcomprising the applicator head of FIG. 4 is held in upright positionsuch that the applicator surface (20) is horizontal. Topical formulationis urged from the packaging and out of the outlet opening (40). Theformulation spreads over the applicator surface (20) in a blob. If afirst dose of formulation is desired, urging is continued until theproduct reaches the first dose marking (60″). If the urging is stoppedwhen the formulation is on an inner edge of first dose marking (60″), onthe first dose marking (60″), or on an outer edge of first dose marking(60″), the dose measured will be within the range of 2 grams +/−10% (wt)of Voltaren arthritis pain. The formulation covers the inner dosingcompartment (64) and the first dose marking (62″). The ring dosingcompartment (66), the second dose marking (62″), and the outercompartment (68) are not covered by product. The amount of product nowpresent on the applicator surface (20) is the predefined first dose,namely 2 grams of Voltaren arthritis pain. The dose indicator (61)reminds a user of an amount of product that is the first dose, in thisembodiment, 2 grams. If a second, higher dose of product is desired,urging is continued until the product reaches and covers the second dosemarking (62″). The product covers the inner dosing compartment (64), thefirst dose marking (60″), the ring dosing compartment (66), and thesecond dose marking (62″). The outer compartment (68) is not covered byproduct. The amount of Voltaren arthritis pain now present on theapplicator surface (20) is the predefined second dose, namely 4.0 gramsof Voltaren arthritis pain. The dose indicator (63) reminds a user of anamount of product that is the second dose, in this embodiment, 4 grams.

FIG. 5 shows an exploded perspective side view of an applicator surfaceof the embodiment of FIG. 4. As in FIG. 3, the dose markings (60″, 62″)is shown removed from the applicator surface (20). This is for betterunderstanding of the configuration and manufacturing only, as the dosemarkings (60″, 62″) are not necessarily configured to be removed fromthe applicator surface (20). The applicator surface (20) of FIG. 4 andFIG. 5 is produced by bi-injection molding. In a first molding step, theapplicator surface (20) is molded from a first material in a firstcolor. Two recesses (67) are foreseen in the applicator surface (20) inthis first molding step. Significantly, the recesses (67) foresee also arecessed space for the bulges surrounding the dose indicators (61, 63).Within these recessed spaces there are formed, still from the firstmaterial in the first color, and during the first molding step, figuresof the dose indicators (61, 63). An arrangement of surface undulations(80) present on the applicator surface (20) is continued on a ground ofthe recess (67). In a second molding step, the recesses are filled witha second material of the first and second dose markings (60″, 62″),which has a second color different from the first color. The amount ofsecond material injected to form the two dose markings (60″, 62″) issufficient to fill the recesses (67). After cooling, dose markings (60″,62″) do not project from the applicator surface (20). Margins of dosemarkings (60″, 62″) flush with margins of recesses (67). Surfaceundulations (80) present on surface of the dose markings (60″, 62″) fitin seamlessly with an arrangement of surface undulations (80) on aremainder of the applicator surface (20). The applicator surface (20)has a smooth surface, regularly rippled due to the surface undulations(80). The dose markings (60″, 62″) have the same thickness as thicknessT of the ring (65) in FIG. 3. Plug (90) is configured as in theembodiment of FIG. 3.

FIG. 6 shows a vertical central cut view of an applicator surface of theembodiment of FIG. 2. Applicator surface (20) has a bumpy or rippledsurface due to surface undulations (80). Furthermore, applicator surface(20) has a slight curvature with a highest point centrally, close to theoutlet opening (40) and a lowest point outwardly, close to the end wall(30). FIG. 6 shows how flow direction A-A′ runs through an inside ofplug (90) and out of outlet opening (40). Plug (90) protrudes from abottom side of the applicator surface (20) in an approximately rightangle. A surface of plug (90) facing the flow direction A-A′ has asmooth surface. Plug (90) is configured to be slidable vis-a-visremaining parts of the applicator head (10).

Fixing elements (32) are foreseen on a bottom of the applicator surface(20). The fixing elements (32) are hooks of about 3.75 mm length. Thereare two fixing elements in the embodiment of FIG. 6 (only 2 shown). Thefixing elements are positioned approximately under the recess (67) andring (65). With fixing elements (32), the applicator head (20) can beaffixed to remaining parts of the applicator head (10) with a snap fitmechanism, such that a user cannot remove it. Additionally, annularfixing element (76) is formed on an end of vertical section of end wall(74) that faces the plug (90). Annular fixing element (76) also affixesto remaining parts of the applicator head by way of snap fit and ensuresthat the applicator surface (20) stays connected to remaining parts ofthe applicator head (10) even when an open and closing mechanismforeseen in the applicator head (10) is opened.

FIG. 7 shows a side view of the embodiment of FIG. 2. Especially, inFIG. 7, the applicator surface (20) of FIG. 2 is affixed to remainingparts of the applicator head (10). From the applicator surface (20),applicator head (10) tapers towards a neck part (12) before it widens upagain towards a tube transition section (18). Tube transition section(18) has a form and dimensions that match a neck part of a tube orcontainer to be used with the applicator head (10). In an upper half ofthe applicator head (10), grip portions (14) are foreseen. There are twogrip portions (14) on opposite sides of applicator head (10). In FIGS. 7and 8, only one grip portion (14) is visible. Grip portions (14) serveto operate an open and closing mechanism foreseen in the applicator head(10). FIG. 7 shows the applicator head (10) in closed position. Inclosed position, the vertical section (74) of end wall (30) meets a body(11) of applicator head (10) in a line of contact (16). To openapplicator head (10), lifting force in the flow direction A-A′ isapplied on the applicator surface (20) through grip portions (14).Applicator surface (20) then lifts about 2.5 mm from body (11) in aslide motion, until it reaches a maximum open position. To close theapplicator head, pulling force is applied on the applicator surface (20)via grip portions (14) in a closing direction A′-A. Applicator surface(20) then slides in this closing direction A′-A until it meets body (11)in a closed position.

FIG. 8 shows a perspective external view of the embodiment of FIG. 2. Itshows that grip portions (14) are designed ergonomically with recessesthat accommodate fingers of a user. The grip portions (14) can thus beeasily grabbed. The open and closing mechanism can thus be operated withtwo fingers, typically a thumb on one grip portion (14) and an indexfinger of the same hand on the second grip portion (14). FIG. 8 alsoshows the applicator head (10) in a closed position. Therefore, there isno distance between the applicator surface (20) and the body (11).

FIG. 9 shows a perspective view of a fourth embodiment. In theembodiment of

FIGS. 9 to 12, the applicator surface comprises a horizontal portion(21) that is perpendicular to flow direction A-A′ and a slanting portion(22) that is angled towards flow direction A-A′. The angle is less than180° . Thereby, the slanting portion (22) forms a sloping edge of theapplicator head (10). The slanting portion (22) forms about 20% to 60%,about 30% to 50%, preferably 40% of the applicator surface (20). Toaccount for the slanting portion (22), and the different, irregularspreading behavior that a topical formulation will have when urged outof the outlet opening (40), the dose markings (60″, 62″) of thisembodiment are partially circular and partially ellipsoid. The parts ofthe dose markings (60″, 62″) on the horizontal portion (21) arecircular, and the parts of the dose markings (60″, 62″) on the slantingportion (22), are ellipsoid. Dose markings (60″, 62″) comprise doseindicators (61, 63). These dose indicators (61, 63) can comprise symbolsor figures indicating the doses to be measured within the first (60″)and second (62″) dose marking. In the figures, those dose indicators(61, 63) are blank.

Dose markings (60″, 62″) are realized on the applicator surface (20) byprinting. The embodiment comprises a conventional cap (100) that can beused to close the applicator head. In the FIGS. 9 to 12, the cap isshown in the open position. There is provided a tamper evidencemechanism comprising a flexible member (200) formed on the cap (100) anda fragile member (210) formed between the applicator surface (20) andend wall (30). Upon an initial first closing of the cap, flexible member(200) hooks under fragile member (210). Upon a first opening of the cap(100), fragile member (210) is lifted by the flexible member (200) andpartially breaks away from the applicator head (10) at foreseen fragilepoints. A user can notice that the applicator head (10) has previouslybeen opened in case the fragile member (210) is not completely attachedto the applicator head (10).

FIG. 10 shows a perspective view of a packaging comprising the head ofthe embodiment of FIG. 9. The applicator head (10) is attached to atube.

FIG. 11 shows a side view of the head of the embodiment of FIG. 9.Especially, the slanting portion (22) is shown. Slanting portion (22) isangled towards flow direction A-A′ and horizontal section (21). Dosemarkings (60″, 62″) are continued of the slanting portion (22), but inan outline that is adjusted to reflect the inclination.

FIG. 12 shows a top view of the head of the embodiment of FIG. 9. Whenthe applicator head (10) of this embodiment is used for dosing of atopical formulation, the topical formulation is urged out of outletopening (40). The topical formulation will then spread on the applicatorsurface (20) over the horizontal portion (21) and also on the slantingportion (22). The topical formulation may spread faster on the slantingportion (22). The outline of the portion of the dose markings (60″, 62″)on the slanting portion (22) can therefore deviate from the circularoutline on the horizontal portion (21). Methods of adjusting the outlineof dose markings (60″, 62″) to particular designs of the applicatorsurface (20), and to flow behavior of topical formulations on thoseapplicator surfaces (20), are described above in the detaileddescription.

Elements, apparatus, and methods described herein, however, are notlimited to the specific embodiments presented in the detaileddescription, examples, and figures. It should be recognized that theexemplary embodiments herein are merely illustrative of the principlesof the present invention. Numerous modifications and adaptations will bereadily apparent to those of skill in the art without departing from thespirit and scope of the invention.

In addition, all ranges disclosed herein are to be understood toencompass any and all subranges subsumed therein. For example, a statedrange of “1.0 to 10.0” should be considered to include any and allsubranges beginning with a minimum value of 1.0 or more and ending witha maximum value of 10.0 or less, e.g., 1.0 to 5.3, or 4.7 to 10.0, or3.6 to7.9.

All ranges disclosed herein are also to be considered to include the endpoints of the range, unless expressly stated otherwise. For example, arange of “between 5 and 10” or “5 to 10” or “5-10” should generally beconsidered to include the end points 5 and 10.

It is further to be understood that the feature or features of oneembodiment may generally be applied to other embodiments, even thoughnot specifically described or illustrated in such other embodiments,unless expressly prohibited by this disclosure or the nature of therelevant embodiments. Likewise, compositions and methods describedherein can include any combination of features and/or steps describedherein not inconsistent with the objectives of the present disclosure.Numerous modifications and/or adaptations of the compositions andmethods described herein will be readily apparent to those skilled inthe art without departing from the present subject matter.

1. An applicator head for administration of a topical formulation,comprising a dosing aid for application of a predefined dose of thetopical formulation, wherein the applicator head comprises an applicatorsurface adapted to apply the topical formulation to a user's skin,wherein the applicator surface comprises an outlet opening, and whereinthe dosing aid comprises a dose marking on the applicator surface,wherein the dose marking circumscribes an inner dosing compartment thatserves to measure the predefined dose of the topical formulation, andwherein the outlet opening is disposed inside the inner dosingcompartment.
 2. An applicator head according to claim 1, wherein thedose marking has an outline that is at least partially circular, thecircular part of the outline having a diameter D.
 3. An applicator headaccording to claim 2, wherein the dose marking has a completely circularoutline.
 4. An applicator head according to claim 2, wherein the dosemarking is partially circular and partially ellipsoid.
 5. An applicatorhead according to claim 2, 3 or 4, wherein the outlet opening isdisposed centrally of the circular part of the outline of the dosemarking.
 6. An applicator head according to claim 1, wherein thediameter D is selected such that, when the topical formulation isejected from the outlet opening, the amount of topical formulation thatspreads from the outlet opening and over the inner dosing compartmentuntil it reaches the dose marking, corresponds to the predefined dose.7. An applicator head according to claim 1, wherein the dose marking isa visual dose marking.
 8. An applicator head according to claim 1,wherein the dose marking is realized on the applicator surface bysurface treatment of the applicator surface, application of colormarkings on the applicator surface, by producing the applicator surfacefrom several materials, wherein a border between two distinct materialsserves as the dose marking, or by moulding-in of the dose marking intothe applicator surface.
 9. An applicator head according to claim 8,wherein the dose marking has a color that is different from the color ofa rest of the applicator surface.
 10. An applicator head according toclaim 1, wherein the dose marking flushes with the applicator surface.11. An applicator head according to claim 1, wherein the dosing aid isadapted for dosing of two predefined doses of topical formulation. 12.An applicator head according to claim 1, wherein there is more than onedose marking on the applicator surface, and wherein the dose markingsare arranged on the applicator surface concentrically around the outletopening.
 13. An applicator head according to claim 12, wherein there area first and a second dose marking on the applicator surface, wherein thefirst dose marking is arranged between the outlet opening and the seconddose marking, and wherein the first and second dose marking between themcircumscribe a ring dosing compartment, and wherein the ring dosingcompartment has a ring width W that is the distance between the firstand the second dose marking.
 14. An applicator head according to claim13, wherein the ring width W is selected such that when the topicalformulation is ejected from the outlet opening, the amount of topicalformulation that spreads from the outlet opening and over the innerdosing compartment and further over the ring dosing compartment, untilit reaches the second dose marking, corresponds to a second predefineddose.
 15. An applicator head according to claim 13, wherein theapplicator surface is manufactured by bi-injection moulding.
 16. Anapplicator head according to claim 13, wherein the diameter D of thefirst dose marking is about 19 mm to about 21 mm.
 17. An applicator headaccording to claim 13, wherein the diameter D of the second dose markingis about 25 mm to about 27 mm and the ring width W is from about 0.8 mmto about 3 mm.
 18. An applicator head for administration of a topicalformulation, comprising a dosing aid for application of a predefineddose of the topical formulation, wherein the applicator head comprisesan applicator surface adapted to apply the topical formulation to auser's skin, wherein the applicator surface comprises multiple outletopenings, and wherein the dosing aid comprises a dose marking on theapplicator surface, wherein the dose marking has an outline that is atleast partially circular, the circular part of the outline having adiameter D, and wherein the outlet openings are disposed on theapplicator surface point symmetrical to a center of the circular part ofthe outline of the dose marking, and wherein the dose markingcircumscribes an inner dosing compartment that serves to measure thepredefined dose of the topical formulation.
 19. A packaging for atopical formulation comprising an applicator head according to claim 1.20. A product comprising a packaging according to claim 19 containing atopical formulation.
 21. A product according to claim 20, wherein thetopical formulation has a viscosity in the range of about 1 Pa·s toabout 4 Pa·s
 22. A method of dosing a topical formulation with apackaging according to claim 19, comprising the steps of: Urging thetopical formulation from the packaging and out of the outlet opening onthe applicator surface, letting the topical formulation spread over theapplicator surface until it covers the inner dosing compartment, andstopping urging of the topical formulation as soon as the topicalformulation covers the inner dosing compartment.